Status:
UNKNOWN
Encapsulated Faecal Microbiota Transplantation to Preserve Residual Beta Cell Function in Type 1 Diabetes Mellitus
Lead Sponsor:
Nordin Hanssen
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this single arm pilot study it will be investigated whether encapsulated autologous fecal microbiota transplantation may be used to halt the decline in residual beta cell function in individuals wi...
Detailed Description
Rationale: The (small) intestinal microbiota composition has been implicated to play an important role in (human) metabolism, as well as autoimmune diseases such as type 1 diabetes mellitus. Faecal mi...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Male or female recently diagnosed (0.5-3.5 years) with type 1 diabetes mellitus.
- Age: 18-65 years
- BMI: 18-30 kg/m2
- Remaining residual beta cell function: detectable plasma C-peptide or urinary Cpeptide at inclusion of the study
Exclusion
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- History or symptoms of other autoimmune disease (e.g. hypo- or hyperthyroidism, rheumatoid arthritis).
- (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency virus (HIV) infection with a CD4 count \< 240/mm3).
- History of a severe disease of the digestive tract, such as celiac disease, chronic diarrhoea (≥3 stools/day for \>4 weeks), chronic obstipation (\<2 defecations/week for \>3 months), Irritable Bowel Syndrome (IBS) (according to Rome IV criteria) or Inflammatory Bowel Disease (IBD).
- Use of antibiotics, antacid drugs or proton pump inhibitors in the past 3 months or during the study period.
- Use of pro-/prebiotics in the past three months or during the study period.
- Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
- Use of \>21 units of alcohol per week on average in the past three months.
- Pregnancy or breast feeding.
- Inability to provide informed consent.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05323162
Start Date
April 1 2022
End Date
October 1 2023
Last Update
April 12 2022
Active Locations (1)
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1
Academisch Medisch Centrum
Amsterdam, Please Select, Netherlands, 1105 AZ